The present invention relates generally to sealing of a percutaneous incision or puncture in the wall of a vessel, duct, lumen or hollow organ in the body of a living being, by positioning a sealing device in said incision or puncture, where the incision or puncture is smaller than said sealing device. In particular the invention relates to a guiding tool for enabling the correct positioning of such a sealing device, ensuring a leak-proof sealing.
In recent years a number of devices and apparatuses have been developed enabling the closure or occlusion of e.g. punctures in the femoral artery following catheterization. Instead of applying a pressure to the puncture site for a period of time sufficient for blood clot formation to occur, the new methods are e.g. based on providing a plug, commonly referred to as an xe2x80x9cartery plugxe2x80x9d, in the puncture. The plug is made of a resorbable material, such that it can be left in place until the tissue has recovered properly and the wound or puncture is healed. The plug can be made of collagen, and applied to the outside of a vessel against a counteracting element, also made of a resorbable material, introduced into the interior of the vessel. A locking means secures the collagen plug in place. A device of this kind is disclosed in U.S. Pat. No. 5,935,147 (Kensey et al). The sealing action is thus performed by the externally applied collagen plug. However, a certain percentage of applied plugs will not be leak-proof and often further compression by other devices or manually must be applied.
Alternatively, a plug can be made of two members such that a first member is positioned within a vessel and acts as the occluding member, and a second member is positioned outside the vessel and locked to the first member by a locking means. In order to ensure leak-proof action, the first member is larger than the puncture in all directions, i.e. it will cover a surface larger than the area of the puncture. In order to make this possible, the first member is foldable. A device of this kind is disclosed in our own EP-application EP-00850184.3 (corresponding to U.S. patent application Ser. No. 09/704,726).
The problem facing all systems wherein a folding or deformation of an element is needed in order to introduce the element into a vessel or through any tissue wherein the hole is smaller than the element itself, is that it can be difficult to achieve a reproducible unfolding, that accurately seals the hole from the inside. Also, in many cases the closure element is provided inside an introducer member such as a tube, in a folded state, already at the time of manufacture of the kit comprising all components. If the kit is stored for extended periods of time, and even for shorter times, the folded closure element most likely does not unfold properly at the time of use. To avoid the risk of permanent deformation, the closure element could be inserted into the introducer device by the physician, but this would require an extra manipulation, and it might be very difficult to maintain the sterility of the devices in such a case.
Thus, in view of the problem with the prior art devices, it is the object of the present invention to improve the rate of successful sealing operations using wound closure devices, when foldable or deformable closure elements are introduced into a vessel through a hole, smaller than the element itself, and to enable the folding and unfolding operation to take place during the sealing operation, and to avoid manipulation of the closure element by the physician at the time of performing the sealing operation.
This object is achieved by the provision of a guiding tool which in a controlled manner deforms or folds a wound closure element such that it after having been introduced through a puncture, unfolds and regains its original shape in a reproducible and controllable manner, and thereby provides adequate sealing at an excellent rate of success, this procedure taking place at the time of performing the sealing operation. The present invention relates to a guiding tool for controllable and reversible folding or deformation of a wound closure element before insertion of the wound closure element into a percutaneous incision or puncture in the wall of a vessel, duct, lumen, or hollow organ in the body of a living being, where the incision or puncture is smaller than the wound closure element in an unfolded or undeformed state. The guiding tool includes a body having a distal end, a proximal end, and a lumen extending between the distal and proximal ends. The guiding tool also includes a wound closure element introduction opening in the proximal end and a wound closure element exit opening in the distal end. The lumen has inner walls provided with wound closure element guiding surfaces. The wound closure element guiding surfaces are adapted to reversibly reduce the spatial extension of a wound closure element during its passage through the guiding tool so that the wound closure element is capable of passing through the incision or puncture and, after passing through the incision or puncture, assumes a shape that is capable of providing a sealing action against the incision or puncture.